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Medicine

Linezolid 100 mg/5 mL powder for oral suspension

Linezolid · Oral
Available on requestPrescription onlyUS FDAGeneric name

Linezolid 100 mg/5 mL powder for oral suspension is a generic prescription medicine for oral use, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20º to 25ºC (68º to 77ºF). Protect from light and moisture.

Key facts

Active ingredient (INN)
Linezolid
Brand
Sold under the generic name
Strength
100 mg/5 mL
Dosage form
Powder for oral suspension
Route
Oral
Packs
150 mL
Manufacturer
Hikma Pharmaceuticals
Origin register
US FDA, United States
Storage
Store at 20º to 25ºC (68º to 77ºF). Protect from light and moisture.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
J01XX08 Linezolid
HS code (indicative)
3004.20Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
3 June 2015
Identifiers
DailyMed set ID 16007ca5-7956-4414-af38-406a6623400eNDC 0054-0319Application ANDA200068

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

PackCodeLabelerMarketed since
150 mL in 1 bottle0054-0319-50Hikma Pharmaceuticals3 June 2015

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 18 April 2000Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Other strengths and forms of Linezolid

Clinical summary

Linezolid is an oxazolidinone antibacterial indicated in adults and children for the treatment of infections caused by susceptible Gram-positive bacteria, among other approved uses. It is available as tablets, injection and oral suspension for intravenous use. MedsAcross supplies Linezolid for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Linezolid

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Linezolid 100 mg/5 mL powder for oral suspension for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.